Canada’s Drug Agency | Drugs, Health Technologies and Systems.

latanoprost

Details

Key Milestones2
Call for patient input posted September 26, 2017
Patient group input closed November 15, 2017
Clarification:

- No patient input submission received
Submission received October 25, 2017
Submission accepted for review November 08, 2017
Review initiated November 09, 2017
Draft CDR review report(s) sent to applicant February 01, 2018
Comments from applicant on draft CDR review report(s) received February 12, 2018
Redaction requests from applicant on draft CDR review report(s) received February 20, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant March 09, 2018
Canadian Drug Expert Committee (CDEC) meeting March 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans April 03, 2018
Embargo period ended and validation of redacted CDR review report(s) received April 17, 2018
CDEC Final Recommendation issued to applicant and drug plans April 24, 2018
CDEC Final Recommendation posted April 27, 2018
Final CDR review report(s) and patient input posted May 17, 2018
Last Updated : May 17, 2018

Kisqali for Metastatic Breast Cancer – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : May 3, 2018

Stivarga for Unresectable Hepatocellular Carcinoma (HCC) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : May 3, 2018

Bavencio for metastatic Merkel Cell Carcinoma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 6, 2018

Cabozantinib for Advanced Renal Cell Carcinoma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : January 25, 2018

nitisinone

Details

Key Milestones2
Call for patient input posted August 31, 2017
Patient group input closed October 23, 2017
Clarification:

- Patient input submission received
Submission received September 29, 2017
Submission accepted for review October 16, 2017
Review initiated October 20, 2017
Draft CDR review report(s) sent to applicant January 24, 2018
Comments from applicant on draft CDR review report(s) received February 02, 2018
Redaction requests from applicant on draft CDR review report(s) received February 09, 2018
Canadian Drug Expert Committee (CDEC) meeting March 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans April 04, 2018
Embargo period ended and validation of redacted CDR review report(s) received April 18, 2018
CDEC Final Recommendation issued to applicant and drug plans April 25, 2018
CDEC Final Recommendation posted April 27, 2018
Final CDR review report(s) and patient input posted April 27, 2018
Last Updated : January 14, 2019

tenofovir alafenamide

Details

Key Milestones2
Call for patient input posted August 30, 2017
Patient group input closed October 20, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups November 02, 2017
Patient group comments on input summary closed November 09, 2017
Clarification:

- Patient input summary feedback received
Submission received September 28, 2017
Submission accepted for review October 13, 2017
Review initiated October 16, 2017
Draft CDR review report(s) sent to applicant January 04, 2018
Comments from applicant on draft CDR review report(s) received January 15, 2018
Redaction requests from applicant on draft CDR review report(s) received January 22, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant February 08, 2018
Canadian Drug Expert Committee (CDEC) meeting February 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans March 05, 2018
Embargo period ended and validation of redacted CDR review report(s) received March 19, 2018
CDEC Final Recommendation issued to applicant and drug plans March 26, 2018
CDEC Final Recommendation posted March 28, 2018
Final CDR review report(s) and patient input posted April 24, 2018
Last Updated : April 30, 2018

Opdivo for classical Hodgkin Lymphoma (after failure of ASCT) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : May 22, 2018

dexamethasone

Details

Key Milestones2
Call for patient input posted August 25, 2017
Patient group input closed October 17, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups October 24, 2017
Patient group comments on input summary closed October 31, 2017
Clarification:

- Patient input summary feedback received
Submission received September 26, 2017
Submission accepted for review October 13, 2017
Clarification:

- Submission was not accepted for review on 2017 Oct 11

- Revised category 1 requirements received on 2017 Oct 13
Review initiated October 16, 2017
Draft CDR review report(s) sent to applicant January 05, 2018
Comments from applicant on draft CDR review report(s) received January 16, 2018
Redaction requests from applicant on draft CDR review report(s) received January 23, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant February 08, 2018
Canadian Drug Expert Committee (CDEC) meeting February 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans March 06, 2018
Embargo period ended and validation of redacted CDR review report(s) received April 18, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested
Applicant's request for reconsideration placed on CDEC agenda October 17, 2018
CDEC Final Recommendation issued to applicant and drug plans October 24, 2018
CDEC Final Recommendation posted October 26, 2018
Final CDR review report(s) and patient input posted November 08, 2018
Last Updated : December 21, 2018

tocilizumab

Details

Key Milestones2
Call for patient input posted August 25, 2017
Patient group input closed October 17, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups October 23, 2017
Patient group comments on input summary closed October 30, 2017
Clarification:

- Patient input summary feedback received
Submission received September 25, 2017
Submission accepted for review October 10, 2017
Review initiated October 11, 2017
Draft CDR review report(s) sent to applicant December 21, 2017
Comments from applicant on draft CDR review report(s) received January 09, 2018
Redaction requests from applicant on draft CDR review report(s) received January 16, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant February 08, 2018
Canadian Drug Expert Committee (CDEC) meeting February 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans March 06, 2018
Embargo period ended and validation of redacted CDR review report(s) received March 20, 2018
CDEC Final Recommendation issued to applicant and drug plans March 27, 2018
CDEC Final Recommendation posted March 29, 2018
Final CDR review report(s) and patient input posted April 24, 2018
Last Updated : April 30, 2018